Novel CRA Training Methods Emerge

Tim Bray

I’ve written previous articles on the CRA shortage, and recently, the Tufts CSDD published more information on the shortage, indicating the two-year minimum CRA experience expectation is dissipating. But how can CROs and sponsors mitigate risks by onboarding CRAs with less experience? In this interview, Tim Bray, chief sourcing and training officer at Virb discusses his perspectives on the topic.

Moe Alsumidaie: How do you choose candidates for the Virb program, and who has the best educational and professional background?

Tim Bray: Our process looks for both hard and soft skills. We work with our clients to provide the skills and background they prefer in a fresh candidate. We do a comprehensive series of interviews and personality testing. We want a demonstrated ability to assimilate complex information and a strong detail orientation. We also look for a strong mix of achievement drive, influencing, and relationship-building skills. We also like to find students who have shown through their major and work that they can multitask and have shown leadership capability.We prefer students that have already bridged the gap in working with healthcare professionals, particularly nurses and physicians. Many of our students have had pharma internships, medical assisting, medical scribing, and/or pharmacy experience. Our most recent batch had students with PharmDs, neuroscience, biotechnology, biology, and chemistry backgrounds. We like exposure to patient care through internships and actual work experience. One of our students had worked in the eCOA space, and another worked as a CRC. Another grew up in Ghana and coordinated a healthcare program with physicians through her church every summer. She has experience in hypertension, diabetes, and glaucoma. It is candidates like these who have excelled at becoming a CRA.

MA: What distinguishes Virb training from other clinical research training programs?

TB: Traditional CRA training courses frequently resemble college-style learning modules in that you learn and are tested on concepts. For example, you may spend a week on informed consent and then take a test. Then you spend another week on another topic, and so forth. Often that training employs low-level instructional design tools, such as pre-recorded lectures and PowerPoint slides created by a trainer. This methodology fails because students usually cram for exams and forget the content. In many cases, the students pay for the training courses themselves. Also, since the students sign up for the courses, there is no selection or interview process.

Novel methodologies, such as spiral learning, help students thoroughly understand and master the content. Virb employs spiral learning. Spiral learning teaches concepts gradually and repeatedly, with each successive encounter reinforcing ideas by building on earlier ones, increasing in complexity and scope. Concepts are revealed piece by piece, continually going deeper as the curriculum progresses. Learning science shows that spiral learning results in up to 60% better retention than traditional mastery learning methods. Practice that is spaced out, interleaved with other learning, and varied produces better mastery, longer retention, and more versatility. In Virb’s CRA curriculum, students learn while doing—while practicing how to monitor clinical trials.

At Virb, we get students into practice monitoring from their second week. We don’t just teach principles and concepts and then test them. We teach them to do the work of monitoring through advanced simulations, role plays, and coaching. They will not only learn to uncover all the relevant issues at the site, but we teach them and test them on having conversations with site staff. They produce actual clinical artifacts like site visit reports, letters, and follow-up in critical mistake analysis so they do not repeat the most common errors in site monitoring. We use closed clinical trial data as the basis for our training, and we use cutting-edge AI-enabled online educational technology that can alert instructors if a student is having difficulty. It can also send students more targeted content to assist them in learning more effectively. We also have a very intense final process to Virb certify the student as ready to monitor.

MA: What skills do clients look for in CRA candidates?

TB: Many clients believe that achievement drive, relationship-building, and influencing skills,s distinguish an average CRA from an exceptional one, so that is why we begin with assessments and interviews. We want to ensure the DNA is already there and do it in a way that removes inherent bias to get more diversity into clinical trials. During training, candidates are provided with a scorecard that evaluates their performance beyond patient safety and protocol; these evaluations include technical compliance and soft skills. In addition, clients receive a final scorecard outlining the candidate’s strengths and development areas. When evaluating our candidates, clients are interested in audit findings and the most frequent CRA errors, such as informed consent, investigational product care, inclusion/exclusion criteria and patient qualification, and patient compliance.

MA: How do you match CRA skills to what the industry currently needs?

TB: We focus our training on building skills our clients say the new CRA will use immediately and then provide the other skills as needed on an ongoing basis. For example, our clients will use new CRAs on cardiovascular outcome studies, dermatology studies and/or remote-based monitoring. We evaluate the effectiveness of our training based on the skills that new hires will need in their first few months and then add skill components as the CRA gains experience.

MA: How does the program address the CRA shortage in clinical research?

TB: We are here to fill this void through efficient and effective training programs and by matching highly qualified and trained candidates with available positions. We are expanding our selection criteria to include personnel interested in lateral moves to fill this vacancy. For instance, we recently recruited a candidate whose business development and proposal work for a DCT technology company provided her knowledge of decentralized clinical trials (DCT). She majored in science, desired a career in the field, and satisfied all of Virb’s qualifications for CRA training. We’re also bringing on people who have some exposure to patient recruitment. We have one candidate who coordinated all vaccines administered by a state Department of Health and assisted in patient recruitment. We are also focusing on recruiting candidates from diverse backgrounds; this is important because cultural diversity is necessary for CRAs and clinical research personnel to represent underrepresented patient and investigator communities. We believe the 2-year experience requirement can adversely impact diverse candidates. I might add that we are beginning to partner with companies in the space to source and train diverse CRCs, as there is a huge need there, and many CRCs become CRAs.

Moe Alsumidaie received funding from Virb for this interview.

Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.